Treatment devices and methods

ABSTRACT

A tissue treatment selection device that has at least one treatment delivery member, a delivery setting circuit that is coupled to the treatment delivery member that is adapted to be deployed into tissue to deliver therapeutic energy to a target tissue zone, and the processing circuit is operable to set treatment parameters in the delivery setting circuit that is operable to set treatment parameters in the delivery setting circuit. The processing circuit is operable to transmit a test signal through the deployed treatment delivery member and to determine deployment status. The treatment selection device has a processing circuit adapted to send a message to a display device that indicates that the deployed treatment delivery member has been determined to be compensable and contains a suggested change in the treatment parameters. Also presented herein is a method of treating a tissue of a patient using the treatment delivery device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. 119(e) to U.S.application Ser. No. 12/489,817, now U.S. Pat. No. 9,681,909, filed Jun.23, 2009 and also U.S. Provisional Application No. 61/074,853, filedJun. 23, 2008, both of which are incorporated herein by reference.

FIELD OF THE INVENTION

The present application relates in general to devices that deliver oneor more treatment modalities. More specifically, the application relatesto devices and methods for using tissue treatment apparatuses that caninclude treatment delivery devices having multiple delivery members; andvarying treatment deliveries through selection mechanisms in increasingefficiency, effectiveness, and safety levels.

BACKGROUND OF THE INVENTION

Current treatment devices utilizing two or more treatment deliverymembers are limited in usefulness due to the fact that during deploymentor during use the spacing or resistance between each member can change,and lead to system disruption and failure. However, the currentinvention provides the advantages of detecting improper deployment aswell as changes in environmental conditions and in certain cases, evenactual and relative delivery member locations such that anyirregularities can be corrected in real-time and if necessary,redeployment can be assured in an efficient manner and for patientbenefit. This invention utilizes novel communication between a generatorand a tissue treatment apparatus such that effective treatments can becarried out, and the tissue treatment apparatus does not shut down.

BRIEF SUMMARY

A treatment selection device is presented herein that has at least onetreatment delivery member. The treatment selection device has a deliverysetting circuit that is coupled to the treatment delivery member. Thetreatment delivery member is adapted to be deployed into the tissue todeliver therapeutic energy to a target tissue zone. The treatmentselection device also has a processing circuit that is operable to settreatment parameters in the delivery setting circuit. The processingcircuit is further operable to transmit a test signal through thedeployed treatment delivery member and to determine whether a deploymentstatus of the deployed treatment delivery member is compensable by achange in the treatment parameters without withdrawing the deployedtreatment delivery member. The treatment selection device has aprocessing circuit that is adapted to send a message to a display devicethat indicates that the deployed treatment delivery member has beendetermined to be compensable and contains a suggested change in thetreatment parameters.

Also presented herein is a method of treating a tissue of a patientusing a treatment delivery device having at least one treatment deliverymember. The method involves piercing a tissue with the treatmentdelivery member so as to deploy the treatment delivery member, applyinga test signal through the deployed treatment delivery member, anddetermining, based on the test signal, whether a deployment status ofthe deployed treatment delivery member is compensable by a change in thetreatment parameters without withdrawing the deployed treatment deliverymember.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a partial elevational view of a tissue treatment apparatusaccording to the present application.

FIG. 2 is a generalized circuit diagram illustrating certain componentsof a tissue treatment apparatus according to the present application.

FIG. 3 is a diagram illustrating certain components of a managementcircuit.

FIG. 4 is a diagram illustrating certain components of a processingcircuit.

FIG. 5 is a diagram illustrating a configuration of multiple selectionmethods in coupling with multiple treatment delivery members.

FIG. 6 is a diagram illustrating a configuration of two selectionmechanisms in coupling with a treatment delivery member.

FIG. 7 is a diagram illustrating an alternate configuration of multipleselection mechanisms in coupling with multiple treatment deliverymembers.

FIG. 8 is a diagram illustrating a tissue treatment apparatus includinga treatment selection device, among other components, according to thepresent application.

FIG. 9 is a flow chart illustrating algorithms for use with a tissuetreatment apparatus according to the present application.

FIGS. 10A-10D show waveforms, respectively, for a voltage level (such asfor radiofrequency (RF)), a detected signal, and data bit to acontroller, with FIG. 10D indicating correlating data in binary form.

DETAILED DESCRIPTION

The present invention can be understood more readily by reference to thefollowing detailed description, examples, drawing, and claims, and theirprevious and following description. However, before the present devices,systems, and/or methods are disclosed and described, it is to beunderstood that this invention is not limited to the specific devices,systems, and/or methods disclosed unless otherwise specified, as suchcan, of course, vary. It is also to be understood that the terminologyused herein is for the purpose of describing particular aspects only andis not intended to be limiting.

The following description of the invention is provided as an enablingteaching of the invention in its best, currently known embodiment. Tothis end, those skilled in the relevant art will recognize andappreciate that many changes can be made to the various aspects of theinvention described herein, while still obtaining the beneficial resultsof the present invention. It will also be apparent that some of thedesired benefits of the present invention can be obtained by selectingsome of the features of the present invention without utilizing otherfeatures. Accordingly, those who work in the art will recognize thatmany modifications and adaptations to the present invention are possibleand can even be desirable in certain circumstances and are a part of thepresent invention. Thus, the following description is provided asillustrative of the principles of the present invention and not inlimitation thereof.

As used throughout, the singular forms “a,” “an” and “the” includeplural referents unless the context clearly dictates otherwise. Thus,for example, reference to “a locking member” can include two or moresuch locking members unless the context indicates otherwise.

Ranges may be expressed herein as from “about” one particular value,and/or to “about” another particular value. When such a range isexpressed, another aspect includes from the one particular value and/orto the other particular value. Similarly, when values are expressed asapproximations, by use of the antecedent “about,” it will be understoodthat the particular value forms another aspect. It will be furtherunderstood that the endpoints of each of the ranges are significant bothin relation to the other endpoint, and independently of the otherendpoint.

As used herein, the terms “optional” or “optionally” mean that thesubsequently described event or circumstance may or may not occur, andthat the description includes instances where said event or circumstanceoccurs and instances where it does not. The term “proximal” meansclosest to a practitioner, and the term “distal” means most distant froma practitioner.

Throughout the present disclosure in its entirety, any and all of theone, two, or more features disclosed herein following the term “example”can be practiced in any combinations of two, three, or more thereof,whenever and wherever appropriate as understood by one of ordinary skillin the art. Some of these examples are themselves sufficient forpractice without being combined with any other features, as understoodby one of ordinary skill in the art. Throughout the present disclosurein its entirety, any and all of the descriptions following the term“example” are for illustration only, without limiting the scope of anyof the referenced terms or phrases either within the context or outsidethe context of such descriptions.

Unless otherwise defined herein, scientific and technical terminologiesemployed in the present disclosure shall have the meanings that arecommonly understood and used by one of ordinary skill in the art. Unlessotherwise required by context, it will be understood that singular termsshall include plural forms of the same and plural terms shall includethe singular. Specifically, as used herein and in the claims, thesingular forms “a” and “an” include the plural reference unless thecontext clearly indicates otherwise. Thus, for example, the reference toa microparticle is a reference to one such microparticle or a pluralityof such microparticles, including equivalents thereof known to oneskilled in the art. Also, as used herein and in the claims, the terms“at least one” and “one or more” have the same meaning and include one,two, three or more. The following terms, unless otherwise indicated,shall be understood to have the following meanings when used in thecontext of the present disclosure.

Other than in the operating examples, or unless otherwise expresslyspecified, all of the numerical ranges, amounts, values and percentagessuch as those for quantities of materials durations of times,temperatures, operating conditions, ratios of amounts, and the likesthereof disclosed herein should be understood as modified in allinstances by the term “about.” Accordingly, unless indicated to thecontrary, the numerical parameters set forth in the present disclosureand attached claims are approximations that can vary as desired. At thevery least, each numerical parameter should at least be construed inlight of the number of reported significant digits and by applyingordinary rounding techniques.

Notwithstanding that the numerical ranges and parameters setting forththe broad scope of the disclosure are approximations, the numericalvalues set forth in the specific examples are reported as precisely aspossible. Any numerical value, however, inherently contains certainerrors necessarily resulting from the standard deviation found in theirrespective testing measurements. Furthermore, when numerical ranges ofvarying scope are set forth herein, it is contemplated that anycombination of these values inclusive of the recited values can be used.

“Formed from” and “formed of” denote open claim language. As such, it isintended that a member “formed from” or “formed of” a list of recitedcomponents as well as materials be a member comprising at least theserecited components as well as materials, and can further include othernon-recited components as well as materials.

Examples provided herein, including those following “such as” and“e.g.,” are considered as illustrative only of various aspects andfeatures of the present disclosure and embodiments thereof, withoutlimiting the scope of any of the referenced terms or phrases eitherwithin the context or outside the context of such descriptions. Anysuitable equivalents, alternatives, and modifications thereof (includingmaterials, substances, constructions, compositions, formulations, means,methods, conditions, etc.) known as well as available to one skilled inthe art can be used or carried out in place of or in combination withthose disclosed herein, and are considered to fall within the scope ofthe present disclosure. Throughout the present disclosure in itsentirety, any and all of the one, two, or more features and aspectsdisclosed herein, explicitly or implicitly, following terms “example”,“examples”, “such as”, “e.g.”, and the likes thereof can be practiced inany combinations of two, three, or more thereof (including theirequivalents, alternatives, and modifications), whenever and whereverappropriate as understood by one of ordinary skill in the art. Some ofthese examples are themselves sufficient for practice singly (includingtheir equivalents, alternatives, and modifications) without beingcombined with any other features, as understood by one of ordinary skillin the art. Therefore, specific details disclosed herein are not to beinterpreted as limiting, but merely as a basis for the claims and as arepresentative basis for teaching one skilled in the art to variouslyemploy aspects and features of the present disclosure in virtually anyappropriate manner.

Conventional devices and designs for tissue treatment devices, includingthose for RF tissue ablation, have a non-changeable positive polarityfor all deployable and non-deployable RF electrodes, and anon-changeable negative polarity for all ground pads (i.e., body-surfacereturn electrodes). Such designs limit the amount of power that can besupplied through the RF electrode and the performance of suchconventional devices. Prior commercialization efforts of bipolar RFdevices have failed in part because such devices have a single RF polecoupled directly to multiple RF electrodes. When one or more of the RFelectrodes is mis-deployed, an asymmetrical electrical field is created.As a result, a tissue treatment device can short out and becomeunusable. The control and adjustment features of the present applicationare lacking in conventional devices and designs for treatment delivery(e.g., radiofrequency ablation), which render them incapable ofdetecting or compensating for mis-deployment of treatment deliverymembers or changing treatment delivery parameters in real time.Physicians using such conventional devices can unknowingly deliverineffective treatment to a patient.

Various examples of treatment selection devices are disclosed in thepresent application. The treatment selection devices can include aprocessor (or processors) that is electrically coupled to multipleselection mechanisms and configured for changing at least one of theselection mechanisms from a first setting to a second setting. Theprocessor can include a microprocessor or a microcontroller. Theselection mechanisms can include relays, transistors, thyristors,semiconductor controlled rectifiers, other switches, and combinations oftwo or more thereof.

In one aspect, the treatment selection device disclosed herein can becoupled to at least one mechanism that is capable of data storage. Theat least one data storage mechanism can be used for recording the firstand second settings, as well as a sequence of one or more settingchanges. The data storage mechanisms can include a non-volatile computermemory, such as read-only memory and flash memory. When electricallycoupled to a treatment source, the treatment selection device, theprocessor therein, as well as the data storage mechanisms therein cancommunicate with the treatment source using a one-way or two-way method.

The treatment selection device can further include mechanisms capable ofenergy storage. The energy storage mechanisms can be used for poweringthe processor as well as for powering the multiple selection mechanisms.The energy storage mechanisms can include capacitors and batteries. Incertain examples, the energy storage mechanisms (also called a powerstorage device) can be configured to be energized by a portion of atreatment energy output or a non-treatment energy output, which can beprovided by a treatment source or an auxiliary energy source. The outputof the energy storage mechanisms can be a direct current, which can havea voltage less than that of the treatment energy.

The treatment selection device can be electrically coupled to a singletreatment source or to multiple treatment sources. A treatment sourcecan be a device such as a generator that is capable of converting oneform of energy to another or otherwise providing energy to the energydelivery device for treatment, therapy or tissue ablation as energymoves from the elongated portion of the energy delivery device to thetreatment delivery members and ultimately to tissue. The treatmentselection device can be electrically coupled to a single treatmentdelivery device that includes multiple treatment delivery members, or tomultiple treatment delivery devices, each including the same ordifferent number of treatment delivery member or members. Each treatmentdelivery member can be electrically coupled to one or more selectionmechanisms in the treatment selection device. Each treatment deliverymember can have a distally positioned electrically conductive outersurface, while the remainder of the treatment delivery member and itselectrical coupling to the treatment selection device can be insulated.

The change in the selection device from the first setting to the secondsetting can effect a change at the treatment delivery device from afirst setting of treatment delivery to a second setting of treatmentdelivery. The change from the first setting to the second setting can beprogrammed to take place automatically without user intervention,provided that certain predetermined conditions are met (such asdetection of mis-deployment of the treatment delivery members, oractivation or termination of treatment procedure). Alternatively, thechange from the first setting to the second setting can be effected byuser intervention, either manually (such as by flipping a switch,pushing a button) or through allowed reprogramming of an algorithm. Thedifference between the first and second settings of treatment deliverycan include different combinations of the treatment delivery membersthrough which the treatment is delivered.

The treatment selection device can further include a sensing mechanismfor sensing the delivery of treatment as well as for sensing thetermination of treatment from the treatment source to the treatmentdelivery device. The sensing mechanism can include a sensing circuit.Algorithms for distributing treatment among the various treatmentdelivery members can involve sequential grouping thereof. Treatment canbe delivered through adjacent pairs of treatment delivery members inbipolar mode consecutively or simultaneously.

Alternatively, treatment can be delivered through non-adjacent pairs oftreatment delivery members in bipolar mode consecutively orsimultaneously. Optionally, the device can be set up to prevent certainpatterns or certain repeated sequences of treatment delivery members forpatient safety or effectiveness. Treatment can also be delivered throughgroups of multiple treatment delivery members paired with other multipletreatment delivery members in bipolar mode. Treatment can further bedelivered through a single selected treatment delivery member, ormultiple selected delivery members, paired with multiple treatmentdelivery members that are substantially equivalently positioned withrespect to three selected treatment delivery members. Treatment canfurther be delivered through one, two or more, or all of the treatmentdelivery members in monopolar mode to ensure that complete treatment isdelivered to the target tissue. Without being limited thereto, thedevices disclosed herein can provide complete and individualizedtreatment delivery controls to individual treatment delivery membersindependent of other such members. Such controls include treatmenton/off switching; treatment parameter assignment (e.g., electricalpolarity, output power level, duration of treatment), and selection ofdifferent groups of treatment delivery members for treatment delivery atany time point, but not limited thereto. With the devices, designs, andalgorithms disclosed herein, tissue treatment rate and efficiency can besignificantly improved.

Alternating the treatment delivery pattern across the multiple treatmentdelivery members (e.g., changing the number of members activelydelivering treatment and their polarities) in a predefined algorithm canoptimize the tissue treatment and can circulate more treatment energythrough the treatment delivery members. Referring now to FIG. 1, atissue treatment apparatus 1 is illustrated therein, which can include ahandle 12 that is coupled to a treatment delivery device 50 thatincludes multiple treatment delivery members 51-57 (e.g., forming anelectrode flower) and the elongated member 10 (e.g., probe). Handle 12of the tissue treatment apparatus can be coupled to a treatment source30 (e.g., generator) that includes multiple treatment delivery members51-57 (e.g., forming an electrode flower) and an elongated member 10(e.g., probe). Handle 12 of the tissue treatment apparatus can becoupled to a treatment source 30 (e.g., generator), and in oneembodiment this coupling can be via a cabling 18.

The tissue treatment apparatus can further include a treatment selectiondevice 20, which can be configured for coupling to treatment source 30through cabling 18 or a separate coupling method. Treatment selectiondevice 20 can be incorporated partially or fully into handle 12 asshown. Alternatively, treatment selection device 20 can be incorporatedpartially or fully in the connection between cabling 18 and handle 12,in the connection between cabling 18 and treatment source 30, alongcabling 18. Treatment selection device 20 can also be located in aseparable unit that is configured for coupling to handle 12 and forcoupling to the treatment source 30. Handle 12 can further include adeployment mechanism 14 (e.g., slider) configured to expose at least aportion of treatment delivery members 51-57 partially or fully out of adistal portion of elongated member 10 (e.g., from a single opening ormultiple openings at its distal and in certain embodiments through oneor more side openings arranged annularly around as well as in certaincases longitudinally along member 10). Deployment mechanism 14 can alsobe configured to retract at least a portion of treatment deliverymembers 51-57 back into elongated member 10. Handle 12 can furtherinclude one or more actuating members 16 for enabling treatment deliverythrough treatment delivery members 51-57 or a portion thereof. One ormore (or each) of treatment delivery members 51-57 can have a distallydisposed treatment delivery outer surface (e.g., being electricallyconductive), while the remainder of the treatment delivery member andits coupling (via, for example, conductor such as copper wire) totreatment selection device 20 can be isolated (e.g., electricallyinsulated) from other treatment delivery members and their coupling totreatment selection device 20. Any two adjacent treatment deliverymembers can have a minimum distance between their respective treatmentdelivery outer surfaces (i.e., two points on the respective two surfacesthat are closest to each other) of 0.5 cm or greater, such as 1.5 cm orgreater, or 2 cm or greater, or 2.5 cm or greater.

Treatment source 30 can be configured for providing one, two or moretreatment modalities, such as electromagnetic (e.g., radiofrequency,microwave) energy, thermal energy modalities, nonthermal (e.g.,electroporative), irreversible electroporation (and other nonthermal orthermal modalities), energy, mechanical (e.g., ultrasound) energy,fluidic materials and compositions, among others, to treatment deliverydevice 50. Treatment delivery device 50 can include two or moretreatment delivery members that are deployable, and in certain cases,non-deployable, configured as described herein or as known to thoseskilled in the art. Examples of deployable treatment delivery membersinclude members 51-57, which can be curved or linear, flexible or rigid,solid or hollow, with or without openings, or combinations of two ormore thereof. Deployable treatment delivery members can be deployedindependently, such as individually, or in groups of two or morethereof, or altogether simultaneously, or in predefined sequences, orcombinations thereof. Examples of non-deployable treatment deliverymembers include one or more distal portions (e.g., segments, bands,strips, coils, spirals) of elongated member 10 (not shown).

In exemplary aspect, treatment source 30 can include a generator (e.g.,a radiofrequency (RF) generator), capable of providing an electricalsignal (e.g., thermal ablative RF energy) as a testing as well as incertain cases a sensing signal or a tissue treatment modality totreatment delivery device 50. Treatment delivery device 50 can includethree or more (e.g., 4, 5, 6, 7 or more) deployable treatment deliverymembers, such as members 51-57. One or more (or each) of the treatmentdelivery members can include one or more lumens configured as fluidconduits as well as wiring conduits for sensors (e.g., thermal sensorssuch as thermocouples). Three or more of the treatment delivery memberscan be configured as electrodes (e.g., RF electrodes). Two or more ofthe treatment delivery members can be deployable with the same ordifferent curvature. One or more of the treatment delivery members canbe deployable substantially without curvature (e.g., linearly). Each ofthe treatment delivery members can independently include a tissuepiercing tip that is closed or open.

Referring now to FIG. 2, a diagrammatic illustration of a tissuetreatment apparatus is shown. Treatment selection device 20 can includea management circuit 60, a processing circuit 70, and a delivery settingcircuit 80. Management circuit 60 can include one or more sensingmechanisms (e.g., sensing circuit) that actively or passively sense oneor more changes in one or more treatment modalities provided fromtreatment source 30 to treatment delivery device 50. Management circuit60 can use the one or more sensing mechanisms to control activation orinitiation of processing circuit 70.

Management circuit 60 can further provide a stored energy to powerprocessing circuit 70 as well as delivery setting circuit 80. Powerstorage device in management circuit 60 can include one or morecapacitors as well as batteries. Management circuit 60 can furtherinclude one or more regulating methods to regulate power output toprocessing circuit 70 as well as delivery setting circuit 80.

Based on the sensed changes (e.g., testing, treatment, error) providedby treatment source 30 that is passed on from management circuit 60,processing circuit 70 can be activated or initiated, remain in thecourse of action (e.g., continue testing or treatment delivery), orcarry out a set of instructions (e.g., to report testing results, toprovide an error message, or to change the setting of delivery settingcircuit 80), among other pre-determined options. Sensed changes intreatment provided by treatment source 30 can include changes betweendelivery on and delivery off, changes (e.g., increases or decreases) instrength (e.g., magnitude in energy level or flow rate), feedbacksignals resulting from physical, chemical, as well as performance data(e.g., temperature, impedance) gathered by sensors, but not limitedthereto.

Delivery setting circuit 80 can include multiple selection mechanisms,such that each of the treatment delivery members in treatment deliverydevice 50 can be electrically coupled to one, two or more of theselection mechanisms in delivery setting circuit. As such, change ofdelivery setting circuit 80 from a first setting to a second setting canresult in a change (e.g., begin, end, increase, decrease) of at leastone treatment delivery member in treatment delivery device 50 in atleast one aspect (such as power on or off status, polarity, amplitude orduration of treatment) of its treatment delivery from a first setting(e.g., treatment delivery enabled, positive polarity connection) to asecond setting (e.g., treatment delivery disabled, negative polarityconnection). Treatment delivery after the setting change can be inaccordance with the second setting of delivery setting circuit 80 aswell as the second treatment delivery setting of the at least onetreatment delivery member of treatment delivery device 50.

In one example, management circuit 60 can sense that treatment isprovided by treatment source 30 (i.e., delivery on), and initiate oractivate processing circuit 70. Power storage device within managementcircuit 60 can be energized during the “delivery on” period. Processingcircuit 70 can decide not to change the setting of delivery settingcircuit 80, and treatment is delivered from treatment source 30 totreatment delivery device 50 through delivery setting circuit 80 at theexisting setting of delivery setting circuit 80. In another example,management circuit 60 can sense that treatment from treatment source 30is terminated (i.e., “delivery off”), and inform processing circuit 70as such. Processing circuit 70 can decide to use the power in the powerstorage device to change delivery setting circuit 80 from a firstsetting to a second setting, such that at least one treatment deliverymember of treatment delivery device 50 is changed from a first treatmentdelivery setting (e.g., treatment delivery enabled) to a secondtreatment delivery setting (e.g., treatment delivery disabled). Whentreatment from treatment source 30 is turned back on again, treatmentdelivery through the at least one treatment delivery member can, as aresult of the change in setting within delivery setting circuit 80during the “delivery off” period, be disabled.

Referring now to FIG. 3, an exemplary management circuit 60 isillustrated, the design of which is capable of accomplishing the sensingand power output functions disclosed herein. Management circuit 60 caninclude a power storage circuit 62.

Power storage circuit 62 can include one, two or more power storagedevice (e.g., capacitors, batteries), such as capacitors C1 and C2.Power storage circuit 62, as illustrated herein, can convert a portionof an incoming energy (e.g., alternating current, such as RF test ortreatment energy, can be voltage modulated or current modulated) intodirect current and store the power for later use. Specifically, incomingenergy can charge capacitor C1, the output of which can be rectified bythe remainder of power storage circuit 62 to charge capacitor C2. In onealternative, power storage circuit 62 can be configured to take incomingdirect current and store the power for later use. In anotheralternative, power storage circuit 62 can include one or more batteriesas power storage devices.

Management circuit 60 can run on a voltage lower than that required fortreatment delivery device 50, such as 50V or less, or 10V or less, or 5Vor less. Management circuit 60 can further include a regulating circuit66, such that output of power storage circuit 62 can be properlyregulated (e.g., stepping down from 10V to 5V) to be suitable forpowering processing circuit 70 and delivery setting circuit 80 (shown inFIG. 2). Power storage devices in regulating circuit 66, such ascapacitor C3, can also serve in part the function of power storage inmanagement circuit 60.

Referring now to FIGS. 2 and 3, management circuit 60 can furtherinclude a sensing circuit 68 that is configured to initiate or activateprocessing circuit 70 when treatment delivery is deemed to be “on”. Forexample, when treatment source 30 includes a generator, the generatorcan send out pulses (e.g., 0.1 second in duration and at 1 Hz, fortesting as well as signaling stand-by mode) when in idle mode. It cantake a certain amount of time (e.g., 1 second) for electrical energy(e.g., RF treatment energy) delivered from the generator to fully chargecapacitor C2 in power storage circuit 62. As such, sensing circuit 68can be configured to sense a continuous electrical energy (e.g., RFtreatment energy) delivery of a predetermined period (e.g., 10 secondsor less, 5 seconds or less, 2 seconds or longer) before initiating oractivating processing circuit 70. The predetermined period can be chosento be sufficiently long (e.g., longer than generator pulse durationsduring testing as well as stand-by modes) to allow energy storagemember(s), such as C1 as well as C2, to be fully charged. This way,processing circuit 70 can not be unintentionally initiated or activatedwhen treatment delivery is not on.

Referring now to FIG. 4, an exemplary processing circuit 70 is shown.Processing circuit 70 can include an integrated circuit 78, such as amicroprocessor. Processing circuit 70 can further include non-volatilecomputer memory. The memory can be for storing pre-programmed deliverysetting sequences as well as other data (e.g., commands, parameters,algorithms, software), as well as recording changes in delivery settings(e.g., treatment delivery on/off) and other events (e.g., erroroccurrences) as they occur during procedures. The memory can bephysically one or more elements separate from the integrated circuit, oronboard the integrated circuit (e.g., as in a microcontroller).

Processing circuit 70 can further include a resetting circuit 72 toensure integrated circuit 78 starts correctly when sensing circuit 68(shown in FIG. 3) senses treatment delivery from treatment source 30being on and initiates or activates integrated circuit 78. Processingcircuit 70 can further include a by-pass filtering circuit 74 to filterpower supply. Processing circuit 70 can further include a testing switchcircuit 76 to reset the multiple selection mechanisms in deliverysetting circuit 80 (FIG. 3) during use as well as testing of theapparatus.

Referring now to FIG. 5, a configuration is shown that includes multipleselection mechanisms in a selection mechanisms array 82 in coupling withmultiple treatment delivery members in a treatment delivery device 50.Selection mechanisms array 82 can be included in delivery settingcircuit 80, as shown in FIG. 2. Multiple selection mechanisms inselection mechanism array 82 can include any and all electronicswitches, such as relays, transistors, thyristors (e.g.,semiconductor-controlled rectifiers), and combinations of two or morethereof, but not limited thereto. Treatment can be delivered throughdifferent subsets (e.g., pairs, triplets, fours, fives, up to all) oftreatment delivery members (e.g., members 51-57) in serial as well as incertain embodiments in parallel to prevent or reduce occurrence of rapidimpedance rising of the neighboring tissue, reconfigure treatmentdelivery pattern to compensate for compensable mis-deployment of one ormore treatment delivery members, increase treatment speed, increasetreatment volume, enhance treatment uniformity and efficiency, reducetreatment duration, enhance treatment safety, as well as reducetreatment error.

Multiple selection mechanisms shown in FIG. 5 can be in one-to-oneelectric coupling with multiple treatment delivery members 51-57 intreatment delivery device 50. Each selection mechanism can be in one oftwo settings at any time: on or off (FIG. 5 shows an example “off”position). Electric coupling of each selection mechanism to treatmentsource 30 can be pre-determined in polarity. When a signal (e.g.,treatment) provided by treatment source 30 is electrical (e.g., RFenergy), each of treatment delivery members 51, 53, 55 and 57 can be inone of two settings at any time: positive electrical polarity (e.g.,RF+) or “off”, while each of treatment delivery members 52, 54, and 56can be in one of two settings at any time: negative electrical polarity(e.g., RF−) or “off”. In one example, an algorithm of treatment/testingdelivery through different subsets of treatment delivery members isillustrated in Table 1 below. Treatment/testing can be delivered throughadjacent pairs of treatment delivery members (e.g., groupings 1-6) inbipolar mode (which is significantly more efficient than monopolar mode)consecutively (as shown) or simultaneously (not shown). Alternatively,treatment/testing can be delivered through non-adjacent pairs oftreatment delivery members (e.g., 51-53, 52-54, 53-55, 54-56, 55-51,56-52) in bipolar mode consecutively or simultaneously.

Optionally, treatment/testing can not be delivered through any one ofthe treatment delivery members during two consecutive pairings of thetreatment delivery members (e.g., to avoid overheating of the treatmentdelivery members during thermal treatment delivery). Treatment/testingcan also be delivered through groups of multiple treatment deliverymembers paired with other multiple treatment delivery members (e.g.,groupings 7-9), also in bipolar mode for high efficiency.Treatment/testing can further be delivered through a single selectedtreatment delivery member (e.g., grouping 10), or multiple selecteddelivery members (e.g., grouping 11), paired with multiple treatmentdelivery members that are substantially equivalently positioned withrespect to the selected treatment delivery member, also in bipolar modefor high efficiency. Treatment/testing can further be delivered throughone, two or more, or all of the treatment delivery members in monopolarmode (not shown) to ensure complete treatment/testing being delivered tothe target tissue.

TABLE 1 Groupings in algorithm RF + Members RF − Members Off Members 151 52 53-57 2 53 54 51-52, 55-57 3 55 56 51-54, 57 4 53 52 51, 54-57 555 54 51-53, 56-57 6 51 56 52-55, 57 7 53, 55 52, 56 51, 54, 57 8 51, 5354, 56 52, 55, 57 9 51, 55 52, 54 53, 56-57 10 57 52, 54, 56 51, 53, 5511 51, 53, 55, 57 52, 54, 56

In another example, a distal portion 11 of elongated member 10′ (asshown in FIG. 8) can be configured as another treatment delivery member58, illustrated in FIG. 6, with polarity and an activation state (suchas negative electrical polarity), in addition to treatment deliverymembers 51-57. Another algorithm of treatment/testing delivery throughdifferent subsets of treatment delivery members in an embodiment wheredelivery member 58 is capable of activation is illustrated in Table 2below.

TABLE 2 Groupings in algorithm RF + Members RF − Members Off Members 151 52 53-57 2 53 54 51-52, 55-57 3 55 56 51-54, 57 4 53 52 51, 54-57 555 54 51-53, 56-57 6 51 56 52-55, 57 7 53, 55 52, 56 51, 54, 57 8 51, 5354, 56 52, 55, 57 9 51, 55 52, 54 53, 56-57

Referring now to FIG. 6, a configuration is shown that illustrates anexample of using multiple selection mechanisms in branched configurationto independently provide any one treatment delivery member with morethan two possible settings. Specifically, when treatment delivery member58 is configured for delivering an electrical signal (e.g., RF energy),two selection mechanisms 86 and 88 can be coupled in a branchedconfiguration to provide treatment delivery member 58 with one of threesettings at any given time: positive or negative electrical polarities(e.g., RF+, RF−), or off.

Referring now to FIG. 7, a configuration is shown that illustrates anexample of using multiple selection mechanisms in branched configurationto independently provide each of two or more treatment delivery memberswith more than two possible settings. Specifically, when treatmentsource 30 is configured to provide an electrical signal (such as RFenergy), multiple selection mechanisms 81, 81′, 83, 83′, 85, 85′, 87,87′, and 89 and 89′ (of a selection mechanisms array 82′) can be coupledin a branched configuration to provide each of treatment deliverymembers 51-57 with various settings. FIG. 7 shows 51-56 as an exampleembodiment, through the states including, but not limited to, anactivation state, and polarity can also be conceivably changed for 57.In one exemplary aspect, in certain configurations, selection mechanism81 can lead to an RF+ setting for treatment delivery members 51-57,while selection mechanism 81′ can lead to an RF− setting for treatmentdelivery members 51′-57′. The additional selection mechanisms ofmechanism array 82′ (mechanisms 83, 83′, 85, 85′, 87, 87′, and 89 and89′) are included to show that additional characteristics or settings ofthe treatment delivery members can be changed in the same way that theRF setting (positive or negative) was changed by 81 and 81′.

Referring now to FIG. 8, an alternative tissue treatment apparatus isillustrated, where treatment selection device 20 can be a handle, adevice positioned along a cable, an electrical connector, or astand-alone box (e.g., a set-top box) configured to be coupled with bothtreatment source 30 and the treatment delivery 50′. Elongated member 10′includes a distal portion 11 having an electrically conductive outersurface, which can be used for treatment delivery member 58 as describedherein above and as also illustrated in FIG. 6. Distal portion 11 can besharpened for piercing into or through at least soft tissues.

The remainder of elongated member 10′ can be substantially isolated,such as being electrically insulated by insulation 13. In one aspect,insulation 13 can have an outer diameter greater than or equal to thatof distal portion 11. Insulation 13 can be fixedly coupled to elongatedmember 10′. Alternatively, insulation 13 or a portion thereof (e.g., anouter insulation sleeve) can be movably coupled to elongated member 10′,such as being able to rotate about as well as slide along elongatedmember 10′. Treatment delivery members 51-57 can each independentlyinclude a distal portion having an electrically conductive outersurface, and these distal portions can be sharpened for piercing into orthrough at least soft tissues. The remainders of treatment deliverymembers 51-57 can be substantially isolated, such as being electricallyinsulated by insulations 91-98, respectively. Insulations 91-98 canindependently have an outer diameter greater than or equal to that ofdistal portions of treatment delivery members 51-57. Insulations 91-98can be fixedly coupled to treatment delivery members 51-57,respectively.

Alternatively, insulations 91-98 or portions thereof (e.g., outerinsulation sleeves) can be movably coupled to treatment delivery members51-57, such as being able to rotate about as well as slide alongtreatment delivery members 51-57. Moveable insulations 91-98 or movableportions thereof can move independently of each other, in groups of twoor more thereof, or be coupled together for simultaneous movement.Adjacent distal ends of insulations 91-98 and insulation 13 can have adistance (equivalent to minimum distance of adjacent conductive surfacesof treatment delivery members 51-57 and distal portion 11) of at least 1cm, such as 1.5 cm or greater, or 2 cm or greater, or 2.5 cm or greater.This distance limitation can reduce or eliminate inadvertent electricalshorting when an electrical signal (e.g., RF energy) is applied betweenthese adjacent conductive surfaces in a bipolar mode. For each oftreatment delivery members 51-57, electrical insulation can extend fromdistal ends of insulations 91-98 continuously in the proximal directionthroughout the entire portions within elongated member 10′, and caninclude the separate conductors that electrically couple treatmentdelivery members 51-57 to treatment selection device 20′, which areshown as insulated wires 59.

A separate conductor that electrically couples distal portion 11 (i.e.,treatment delivery member 58) of elongated member 10′ to treatmentselection device 20′ is also completely insulated and included ininsulated wires 59. The complete electrical insulation of eachelectrically conductive outer surface from the others can allowcompletely independent and full control of each electrically conductiveouter surface at any time before, during, or after testing as well astreatment delivery, and can make it possible for real time, in situ,reassignment of settings (e.g., on/off, negative/positive polarity) forany one of the treatment delivery members.

The treatment selection device 20′ can be electrically coupled to asingle treatment source 30 or multiple treatment sources. The multipletreatment sources can be the same as or different from each other intreatment modality, treatment output capability, as well as othercharacteristics. The treatment selection device can be electricallycoupled to a single treatment delivery device 50′ or multiple treatmentdelivery devices. Each of such treatment delivery devices can have asingle treatment delivery member or multiple treatment delivery members.The multiple treatment delivery devices can be the same as or differentfrom each other in the number of treatment delivery members,construction (e.g., size, shape, material composition), configuration,as well as functionalities (e.g., with or without sensors such asthermal sensors, lumens such as infusion as well as cooling andaspiration lumens). The multiple treatment delivery members in atreatment delivery device can be the same as or different from eachother in manner of deployment (e.g., direction, curvature, location),construction (e.g., shape, size, material composition), configuration,as well as functionalities (e.g., with or without sensors such asthermal sensors, lumens such as infusation, as well as cooling andaspiration lumens). The treatment volumes provided by the treatmentdelivery members of the same treatment delivery device or multipletreatment delivery devices can overlap into a desired treatment zonethat substantially cover a selected tissue volume targeted fortreatment.

Methods disclosed herein include methods of tissue treatment usingalgorithms grouping different subsets of multiple treatment deliverymembers or the same subset of the treatment delivery members indifferent configurations for testing as well as treatment delivery, andmethods of using the treatment apparatus disclosed herein for tissuetreatment. One exemplary method includes: delivering a treatmentmodality from a treatment source through a treatment selection device ata first selection setting to a treatment delivery device at a firstdelivery setting, wherein the treatment selection device comprisesmultiple selection mechanisms, and the treatment delivery devicecomprises multiple treatment delivery members; changing the treatmentselection device from the first selection setting to a second selectionsetting; and delivering the treatment modality from the treatment sourcethrough the treatment selection device at the second selection settingto the treatment delivery device, such that the treatment deliverydevice delivers the at least one treatment modality at a second deliverysetting. The first and second selections settings can be different inthe setting of at least one of the multiple selection mechanisms (e.g.,on verses off, positive polarity verses negative polarity). The firstand second delivery settings can be different in the setting of at leastone of the multiple treatment delivery members (e.g., delivery enabledverses disabled, positive polarity verses negative polarity).

The method of delivery can further include employing a processingcircuit to change the treatment selection device from the firstselection setting to the second selection setting. The method canfurther include sensing a change in the delivery of the at least onetreatment modality from the treatment source to the treatment deliverydevice prior to changing the selection setting. The method can furtherinclude powering the processing circuit with a power storage device. Themethod can further include deriving a direct current power from the atleast one treatment modality delivered from the treatment source.

One exemplary method of using the tissue treatment apparatus disclosedherein can include: providing a tissue treatment apparatus that includesa treatment delivery device that is electrically coupled to a treatmentselection device, wherein the treatment selection device includesmultiple selection mechanisms, and the treatment delivery deviceincludes multiple treatment delivery members; placing the treatmentdelivery device into or adjacent to a target tissue; delivering atreatment modality from a treatment source through the treatmentselection device at a first selection setting and through the treatmentdelivery device at a first delivery setting to the target tissue;changing the treatment selection device from the first selection settingto a second selection setting; and delivering the treatment modalityfrom the treatment source through the treatment selection device at thesecond selection setting and through the treatment delivery device tothe target tissue, such that the treatment delivery device delivers thetreatment modality at a second delivery setting. The first and secondselections settings can be different in the setting of at least one ofthe multiple selection mechanisms (e.g., “on” verses “off”). The firstand second delivery settings can be different in the setting of at leastone of the multiple treatment delivery members (e.g., delivery enabledverses disabled, positive polarity verses negative polarity).

The method of delivery can further include employing a processingcircuit to change the treatment selection device from the firstselection setting to the second selection setting. The method canfurther include sensing a change in the delivery of the at least onetreatment modality from the treatment source to the treatment deliverydevice prior to changing the selection setting. The method can furtherinclude powering the processing circuit with a power storage device. Themethod can further include deriving a direct current power from the atleast one treatment modality delivered from the treatment source.

As non-limiting examples of control features suitable for the tissuetreatment apparatuses disclosed herein, the selection mechanisms allowmodes of operation with different characteristics to be combined in anydesirable manner. For example, the selection mechanisms can enable thetreatment delivery members or subsets thereof running in bipolar mode(e.g., in RF energy delivery, such as for tissue ablation) to be carriedout in serial as well as in parallel. Without being limited thereto, itis believed that the bipolar mode is more efficient than the monopolarmode, thereby allowing faster treatment of the tissue between thetreatment members (e.g., raising tissue temperature between theelectrodes quickly to ablation range). The same selection mechanism canthen enable the treatment delivery members or subsets thereof to run inmonopolar mode. Monopolar mode is believed to be better in promoting thegrowth of the treatment volume, allowing a larger treatment volume to beachieved, if desirable.

Referring now to FIG. 9, a flow chart is shown to illustrate algorithmsfor use with a tissue treatment apparatus such that errors in deploymentof the treatment delivery members can be determined and corrected. Asshown, a treatment delivery device is coupled to the treatment source99, the delivery device is positioned, and treatment delivery membersare deployed in target tissue 101. A test signal is sent to treatmentdelivery members for deployment verification 103. The status ofdeployment is then determined as labeled by example categories such asgood, compensable or noncompensable 105. A compensable error such asmoderate mis-deployment is then compensated by the algorithm 107,treatment is commenced 111, at which time a check for errors can be madeby performing any associated algorithms 113 to ensure that thedeployment configuration remains within acceptable limits throughouttreatment. If there are no errors through treatment, treatment will besuccessfully completed 115. Alternatively, if deployment isnon-compensable (such as severe mis-deployment) or if errors are foundin the check for errors during treatment 113, then a request isinitiated for redeployment 109, and a test signal is once again sent totreatment delivery members 103. If deployment is subsequently optimal orwithin compensable limits, treatment can be completed (107-115).

FIGS. 10A-10D show waveforms, respectively, for a voltage level (such asfor RF), a detected signal, and data bit to a controller, with FIG. 10Dindicating correlating data in binary form. More specifically, FIGS.10A-10D show how energy can be used to send a signal for communicationbetween the generator and switching mechanisms of the tissue treatmentapparatus. FIG. 10A shows a waveform 117 indicating voltage (such as RFvoltage) that in one embodiment would be sent from the generator usingthe same path as for the treatment modality (such as RF administration).The voltage is shown in certain embodiments in bursts of approximately0.01 to 0.1 second in length of time (though embodiments could beenvisioned that are longer, including, but not limited, to twice orthree times that range), at 460 KHz and from zero to four volts. FIG.10B shows a waveform 119 for a detected signal showing voltage from zeroto four volts (showing the voltage at a sense line), FIG. 100 depicts awaveform (121) showing data bit to the controller over time, and thebinary code (data) is show (FIG. 10D (123)) corresponding to the sentinformation.

Using this method, standard serial protocols can be used to sendmessages to the selection mechanisms. Typical non-limiting examplemessages would be “turn on switch 5,” “turn on switch 12,” or “turn offall switches.” When treatment commences, no signaling is requiredbecause the relays are set in the correct clinical position, andtreatment (such as RF treatment in one embodiment) is applied to thecorrect pins. Once the treatment using these pins is over, the voltagesent over the line used to send information from the generator insubclinical “signaling mode” as shown in FIGS. 10A-10D and new commandsare sent to the selection mechanisms. In one aspect, in additionalembodiments, the selection mechanisms and the generator are capable ofcommunication).

In one aspect, the generator can utilize user input or informationgathered from sensors from treatment delivery members for resistance,temperature, time, or other modalities (or time of treatment) todetermine when to send a signal to the microprocessors, circuits, andswitches involved in altering or changing energy delivery to treatmentdelivery members in order to change the polarity, pattern of activation(which members are activated at all or what order or for what time), oractivation levels of treatment delivery members. Due to the fact theactual switching occurs within the handle of the tissue treatmentapparatus, and the fact that the treatment voltage and voltages used tosignal changes utilize the same path, there is no need for additionalwires. This is a significant advantage over current technologies due tothe bulk and complexity necessary to contain extra wiring necessary tocommunicate similar signals and which could become impractical orunreasonable depending on the apparatus and treatment complexity.

In one aspect, the treatment delivery device, alone or in combinationwith the treatment selection device, can be configured as a disposableunit to be connected by a user to the treatment source. Recognition ofthe disposable unit by the treatment source, which can include theidentification one or more of device type (treatment modality designedfor), manufacturer, make, model, production date, expiration date, usehistory, but not limited thereto, can take place before, during, orafter the connection. The disposable unit can include a communicationdevice or devices for the recognition process. Non-limiting examples ofsuch communication devices include ID tags (e.g., RFID), transponders,print patterns (e.g., bar code, pixel patterns), and electroniccircuits. In particular, recognition can take place during or afterconnection of the disposable unit to the treatment source when anelectric circuit is used as the communication device. Such an electriccircuit can be incorporated in the treatment delivery device as well asthe treatment selection device as disclosed herein, and can enableone-way communication (e.g., generator reading information from thedisposable unit) or two-way communication (e.g., generator write/recordinformation onto memory within the disposable unit, in addition togenerator reading information from the disposable unit).

After the disposable unit is connected to the treatment source, andoptional disposable unit recognition takes place, the treatment deliverydevice of the disposable unit can be positioned into or adjacent to aselected target tissue. In one aspect, the target tissue selection aswell as the device positioning can involve one or more of biologicalimaging, such as optical (e.g., laparoscope, endoscope), ultrasound,computer tomography, magnetic resonance, fluoroscopy, and others knownto those of ordinary skill in the art. The deployable treatment deliverydevice.

In one aspect, the treatment source, or an auxiliary electric device,can send one or more testing signals to the multiple treatment deliverymembers of the treatment delivery device to verify proper positioning aswell as deployment. The testing signals can be 10% or less than theenergy level used during treatment delivery. The testing signals can beelectrical pulses delivered between any two treatment delivery members,and the results (e.g., voltage, current, impedance) can be used toindicate the distances between the treatment delivery members. In onenon-limiting example, very low impedances can indicate that thecorresponding treatment delivery members are deployed too closetogether. When only a few (e.g., 2 or 3) treatment delivery members areidentified as being mis-deployed, the algorithm can deem suchmis-deployment compensable, and can treat the closely deployed treatmentdelivery members as a single treatment delivery member. That is, thesettings of the closely deployed treatment delivery members (e.g.,on/off, positive/negative polarity assignment) can be forced by thealgorithm to be the same and change together at all times during theprocedure following the device placement. In another aspect, when morethan a few treatment delivery members are identified as beingmis-deployed, the algorithm can deem such mis-deployment severe, andoutput one or more perceptible signals (e.g., error message on a graphicuser interface) to request the user to re-deploy as well as re-positionthe treatment delivery device. Following such re-positioning as well asre-deployment, the testing is carried out again to verify properpositioning as well as deployment.

When the proper positioning as well as deployment of the treatmentdelivery device is verified to be acceptable, treatment delivery can becommenced by the user. The treatment delivery algorithm(s) as describedherein above can be executed to deliver the desired treatment. Thenerror checking subroutines can be executed to verify the completeness aswell as uniformity of the treatment. Error checking subroutines can besimilar to the testing subroutines described herein above for verifyingthe positioning as well as deployment of the treatment delivery members.If an error is identified, the algorithm can initiate a request to theuser for re-positioning as well as redeployment of the treatmentdelivery device to repeat the procedure, until the error is cleared,thereby ensuring effective treatment is delivered, and treatment issuccessfully completed. Then the treatment source can be turned off, thetreatment delivery device can be retracted and removed from the patient,and any open wound can be dressed properly as needed.

The treatment apparatus of the present application includes thefollowing features, but are not limited thereto. The treatment selectiondevice can be configured to use testing as well as high-intensitytherapeutic energy (e.g., RF energy for tissue ablation) from agenerator to convert to low-voltage direct current (DC) power. Thisconverted DC power can be used to power circuits within the treatmentselection device, including communicating with the processor therein(e.g., microprocessor) and to deliver power to it. The processor canallow a testing electric pulse to run through all the treatment deliverymembers to ensure proper deployment thereof, and communicate the resultsto the generator (e.g., one-way communication). Minor misalignment ofthe treatment delivery members can be compensated by the algorithm(e.g., treating the misaligned treatment delivery members as a singlemember), while major misalignment can require the physician to reinsertas well as re-deploy the treatment delivery device. After the treatmentdelivery members are deployed to satisfaction, the algorithm can havethe processor distribute treatment (e.g., therapeutic energy) to thetreatment delivery members according to the various sequential groupingsinstruction in the algorithm that is preprogrammed into the processor.The distribution of treatment can involve the use of selectionmechanisms (e.g., latch relays). The number of selection mechanisms inthe circuit can depend on the number of treatment delivery members inthe treatment delivery device. The algorithm(s) can maximize the volumeto time ratio for treating the tissue.

Although several embodiments of the invention have been disclosed in theforegoing specification, it is understood by those skilled in the artthat many modifications and other embodiments of the invention will cometo mind to which the invention pertains, having the benefit of theteaching presented in the foregoing description and associated drawings.It is thus understood that the invention is not limited to the specificembodiments disclosed hereinabove, and that many modifications and otherembodiments are intended to be included within the scope of the appendedclaims. Moreover, although specific terms are employed herein, as wellas in the claims which follow, they are used only in a generic anddescriptive sense, and not for the purposes of limiting the describedinvention, nor the claims which follow.

The invention claimed is:
 1. A tissue treatment apparatus, comprising: atreatment source, the treatment source configured to generateirreversible electroporation (IRE) for delivery to a target tissue zone;a treatment delivery device comprising at least a first treatmentdelivery member and a second treatment delivery member, each to bedeployed into tissue to deliver the irreversible electroporation to thetarget tissue zone; and a processing circuit programmed to: set aplurality of treatment parameters; transmit a test signal through atleast one of the deployed first treatment delivery member and thedeployed second treatment delivery member; and determine whether thedeployed first treatment delivery member or the deployed secondtreatment delivery member has been mis-deployed prior to treatment basedupon a depth of the deployed first treatment delivery member or thedeployed second treatment delivery member, and a distance between thedeployed first treatment delivery member and the deployed secondtreatment delivery member; and determine a change to at least one of theplurality of treatment parameters to compensate for the mis-deploymentof the first treatment delivery member or the second treatment deliverymember without withdrawing the deployed first treatment delivery memberor deployed second treatment delivery member from the target tissuezone.
 2. The tissue treatment apparatus of claim 1, wherein theprocessing circuit is programmed to automatically change the at leastone of the plurality of treatment parameters to compensate for themis-deployment of the first treatment delivery member or the secondtreatment delivery member.
 3. The tissue treatment apparatus of claim 1,wherein the processing circuit is programmed to send a message to adisplay device that indicates that the deployed first treatment deliverymember or the deployed second treatment delivery member has beenmis-deployed prior to treatment.
 4. The tissue treatment apparatus ofclaim 1, wherein the processing circuit is programmed to send a messageto a display device that indicates the determined change to at least oneof the plurality of treatment parameters to compensate for themis-deployment of the first treatment delivery member or the secondtreatment delivery member.
 5. The tissue treatment apparatus of claim 1,wherein the processing circuit is further programmed to determine thedistance between the deployed first treatment delivery member and thedeployed second treatment delivery member based upon an impedencemeasurement from the test signal.
 6. A tissue treatment apparatus,comprising: a treatment source, the treatment source configured togenerate irreversible electroporation (IRE) for delivery to a targettissue zone; a treatment delivery device comprising a longitudinal shaftand at least two treatment delivery members to be deployed into tissueto deliver irreversible electroporation to the target tissue zone,wherein the at least two treatment delivery members are deployedradially outwardly from the longitudinal shaft of the treatment deliverydevice into the target tissue zone; and a processing circuit programmedto: set a plurality treatment parameters; transmit at least one testsignal through the at least two deployed treatment delivery members; anddetermine that at least one of the least two deployed treatment deliverymembers has been mis-deployed prior to treatment based upon a depth ofthe least two treatment delivery members, and a distance between the atleast two treatment delivery members; and determine a change to at leastone of the plurality of treatment parameters to compensate for themis-deployment of at least one of the least two deployed treatmentdelivery members without withdrawing the at least two treatment deliverymembers from the target tissue zone.
 7. The tissue treatment apparatusof claim 6, wherein: the processing circuit is further programmed todetermine the distance between the at least two treatment deliverymembers based upon an impedence measurement from the test signal.